Division Test conditions

The hydrolysis rate for pH 4, 7 and 9 under sterile conditions in the absence of light shall be determined and reported at 20 °C or 25 °C. For active substances that are stable or have a low rate of hydrolysis at 20-25 °C, the rate shall be determined at 50 °C, or another temperature above 50 °C. If degradation is observed at 50 °C or above, the degradation rate at at least three other temperatures shall be determined and an Arrhenius plot shall be constructed to permit an estimate to be made of hydrolysis rate at 20 °C and 25 °C. The identity of hydrolysis products formed and the rate constants observed, shall be reported. The estimated DegT50 values shall be reported for 20 °C or 25 °C.